SOP for Drug-Device Combination Products Oversight

{
“@context”: “https://schema.org”,
“@type”: “Article”,
“mainEntityOfPage”: {
“@type”: “WebPage”,
“@id”: “https://www.clinicalstudies.in/sop-for-drug-device-combination-products-oversight”
},
“headline”: “SOP for Drug-Device Combination Products Oversight”,
“description”: “This SOP outlines the oversight procedures for clinical trials involving drug-device combination products. It ensures compliance with FDA, EMA, CDSCO, WHO, and ICH GCP requirements for accountability, labeling, risk management, quality oversight, and reporting.”,
“author”: {
“@type”: “Organization”,
“name”: “ClinicalStudies.in”
},
“publisher”: {
“@type”: “Organization”,
“name”: “ClinicalStudies.in”,
“logo”: {
“@type”: “ImageObject”,
“url”: “https://www.clinicalstudies.in/logo.png”
}
},
“datePublished”: “2025-08-26”,
“dateModified”: “2025-08-26”
}

Published on 22/12/2025

Standard Operating Procedure for Drug-Device Combination Products Oversight

SOP No.	CR/OPS/108/2025
Supersedes	NA
Page No.	1 of 46
Issue Date	26/08/2025
Effective Date	01/09/2025
Review Date	01/09/2026

Table of Contents

Purpose

The purpose of this SOP is to establish standardized oversight procedures for clinical trials involving drug-device combination products. It ensures that both drug and device components are managed, documented, and

monitored in compliance with global regulatory requirements, maintaining subject safety and data integrity.

Scope

This SOP applies to sponsors, investigators, CROs, vendors, and site staff engaged in the conduct of drug-device combination clinical trials. It covers accountability, labeling, storage, calibration, quality oversight, safety monitoring, adverse event reporting, and regulatory submissions.

Responsibilities

Sponsor: Ensures oversight of drug-device combination products, including regulatory compliance and quality management.
Investigator/Site Staff: Maintain accountability and logs for both drug and device components.
CRO: Monitors site compliance and supports sponsor oversight.
QA: Audits documentation and verifies compliance with GCP.
Vendors: Provide calibration, labeling, and certification support.

Accountability

The Sponsor’s Quality Lead is accountable for ensuring drug-device combination product compliance. Investigators are accountable for site-level management of products. QA is accountable for verification and audit readiness.

Procedure

1. Product Receipt and Accountability
1.1 Record receipt of drug-device products in the Combination Product Accountability Log (Annexure-1).
1.2 Verify labeling, packaging, and integrity upon receipt.
1.3 Store products according to defined environmental conditions.

2. Labeling and Identification
2.1 Ensure labeling includes “For Clinical Trial Use Only” and UDI identifiers.
2.2 Document labeling in the Labeling Log (Annexure-2).

3. Storage and Handling
3.1 Store per drug storage guidelines (e.g., temperature, humidity) and device requirements (e.g., calibration status).
3.2 Restrict access to authorized personnel only.

4. Calibration and Maintenance
4.1 Ensure device components undergo calibration per manufacturer requirements.
4.2 Record activities in Calibration and Maintenance Log (Annexure-3).

5. Risk Management
5.1 Conduct risk assessment for drug-device interactions and trial-specific risks.
5.2 Document in Risk Assessment Log (Annexure-4).

6. Safety Monitoring and AE Reporting
6.1 Monitor both drug and device components for adverse events or malfunctions.
6.2 Report adverse events, device deficiencies, and malfunctions to sponsor, EC/IRB, and regulators as applicable.

7. Regulatory Submissions
7.1 Submit required documentation for combination products to FDA, EMA, CDSCO, or other authorities.
7.2 Maintain submission records in Regulatory Submission Log (Annexure-5).

8. Archiving
8.1 Archive all accountability, labeling, and safety records in TMF/ISF.
8.2 Retain as per regional archiving regulations.

Abbreviations

SOP: Standard Operating Procedure
QA: Quality Assurance
CRO: Contract Research Organization
TMF: Trial Master File
ISF: Investigator Site File
AE: Adverse Event
UDI: Unique Device Identification
FDA: Food and Drug Administration
EMA: European Medicines Agency
CDSCO: Central Drugs Standard Control Organization
WHO: World Health Organization

Documents

Combination Product Accountability Log (Annexure-1)
Labeling Log (Annexure-2)
Calibration and Maintenance Log (Annexure-3)
Risk Assessment Log (Annexure-4)
Regulatory Submission Log (Annexure-5)

References

Version: 1.0

Approval Section

Prepared By	Ravi Kumar, Clinical Operations Specialist
Checked By	Sunita Reddy, QA Officer
Approved By	Dr. Anil Sharma, Head Clinical Operations

Annexures

Annexure-1: Combination Product Accountability Log

Date	Product ID	Drug Component	Device Component	Received By	Status
01/09/2025	CP-101	Injectable Drug	Infusion Pump	Site Coordinator	Received

Annexure-2: Labeling Log

Date	Product ID	Label Text	Applied By	Verified By
05/09/2025	CP-101	For Clinical Trial Use Only	Packaging Team	QA Officer

Annexure-3: Calibration and Maintenance Log

Date	Device Component	Activity	Performed By	Status
10/09/2025	Infusion Pump	Calibration	Vendor Engineer	Completed

Annexure-4: Risk Assessment Log

Date	Product ID	Risk Identified	Impact	Mitigation
12/09/2025	CP-101	Incorrect infusion rate	High	Double verification at site

Annexure-5: Regulatory Submission Log

Date	Agency	Submission Type	Submitted By	Status
20/09/2025	FDA	Combination Product IND	Regulatory Affairs	Submitted

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
26/08/2025	00	Initial version	New SOP creation	Head Clinical Operations

For more SOPs visit: Pharma SOP